HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
6.9.2011 Official
Journal
of
the
European
Union L
229/9
COMMISSION IMPLEMENTING REGULATION (EU) No 888/2011
of 5 September 2011
concerning the authorisation of diclazuril as a feed additive for turkeys for fattening (holder of
authorisation Janssen Pharmaceutica N.V.) and amending Regulation (EC) No 2430/1999
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
cation was submitted for the re-evaluation of diclazuril as
a feed additive for turkeys for fattening, requesting that
additive be classified in the additive category ‘cocci
diostats and histomonostats’. That application was
accompanied by the particulars and documents required
Having regard to the Treaty on the Functioning of the European
under Article 7(3) of Regulation (EC) No 1831/2003.
Union,

Having regard to Regulation (EC) No 1831/2003 of the
(4) The
European
Food
Safety
Authority
(the
Authority)
European Parliament and of the Council of 22 September
concluded in its opinion of 16 March 2011 ( 7 ) that,
2003 on additives for use in animal nutrition ( 1 ), and in
under the proposed conditions of use, diclazuril does
particular Article 9(2) thereof,
not have an adverse effect on animal health, consumer
health or the environment, and that it is effective in
controlling coccidiosis in turkeys for fattening. It
concluded that no safety concerns would arise for users
provided that appropriate protective measures are taken.
Whereas:
It also verified the report on the method of analysis of
the feed additive in feed submitted by the Community
Reference Laboratory set up by Regulation (EC) No
1831/2003.
(1) Regulation
(EC)
No
1831/2003
provides
for
the
author
isation of additives for use in animal nutrition and for
the grounds and procedures for granting such author
isation. Article 10 of that Regulation provides for the
re-evaluation of additives authorised pursuant to
(5) The
assessment
of
diclazuril
shows
that
the
conditions
Council Directive 70/524/EEC ( 2 ).
for authorisation, as provided for in Article 5 of Regu
lation (EC) No 1831/2003, are satisfied. Accordingly, the
use of that preparation should be authorised as specified
in the Annex to this Regulation.
(2) Diclazuril,
CAS
number
101831-37-2,
was
authorised
for 10 years in accordance with Directive 70/524/EEC
as a feed additive for use on chickens for fattening,
chickens reared for laying up to 16 weeks and turkeys
up to 12 weeks by Commission Regulation (EC) No
(6)
As a consequence of a new authorisation being granted
2430/1999 (
by this Regulation, the entry in Regulation (EC) No

3 ). The additive was subsequently entered
in the Community Register of feed additives as an
2430/1999 concerning diclazuril should be deleted.
existing product, in accordance with Article 10(1) of
Regulation (EC) No 1831/2003. Its use has further
been authorised for 10 years for chickens for fattening
by Commission Regulation (EU) No 1118/2010 ( 4 ), for
guinea fowls by Commission Regulation (EU) No
(7)
Since the modifications to the conditions of authorisation
169/2011 (
are not related to safety reasons, it is appropriate to allow

5 ) and for rabbits by Commission Regulation
(EC) No 971/2008 (
a transitional period for the disposal of existing stocks

6 ).
of premixtures and compound feed containing this
preparation, as authorised by Regulation (EC) No
2430/1999 for use on turkeys up to 12 weeks.
(3) In
accordance
with
Article
10(2)
in
conjunction
with
Article 7 of Regulation (EC) No 1831/2003, an appli
( 1 ) OJ L 268, 18.10.2003, p. 29.
(8) The
measures
provided
for
in
this
Regulation
are
in
( 2 ) OJ L 270, 14.12.1970, p. 1.
accordance with the opinion of the Standing
( 3 ) OJ L 296, 17.11.1999, p. 3.
Committee on the Food Chain and Animal Health,
( 4 ) OJ L 317, 3.12.2010, p. 5.
( 5 ) OJ L 49, 24.2.2011, p. 6.
( 6 ) OJ L 265, 4.10.2008, p. 3.
( 7 ) EFSA Journal 2011; 9(4):2115.

---

L 229/10
EN
Official Journal of the European Union
6.9.2011
HAS ADOPTED THIS REGULATION:
Article 3
Premixtures and compound feed labelled in accordance with
Article 1
Directive 70/524/EEC and containing diclazuril, as authorised
The preparation specified in Annex, belonging to the additive
by Regulation (EC) No 2430/1999 for use on turkeys up to 12
category ‘coccidiostats and histomonostats’ is authorised as an
weeks, may continue to be placed on the market and used until
additive in animal nutrition subject to the conditions laid down
the existing stocks are exhausted.
in that Annex.
Article 2
Article 4
The entry in Annex II to Regulation (EC) No 2430/1999
concerning the diclazuril for turkeys, identified with registration
This Regulation shall enter into force on the 20th day following
number 27, is deleted.
its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 September 2011.
For the Commission
The President
José Manuel BARROSO

---

6.9.2011 Off
ANNEX
Minimum Maximum
content
content
Maximum
Identification Name of the
Species or
Residue Limits
number of
holder of
Additive
Composition, chemical formula, description, analytical
category of
Maximum
mg of active
Other provisions
End of period of
(MRLs) in the
the additive
authorisation
(Trade name)
method
animal
age
substance/kg of
authorisation
relevant
EN
complete feedingstuff
foodstuffs of

with a moisture
animal origin
content of 12 %
Coccidiostats and histomonostats
5 1 771 Janssen
Phar Diclazuril
Additive composition:
Turkeys for
—
1
1 1.
The
additive
shall
26 September 1 500 μg
maceutica
0,5 g/ 100 g
fattening
be incorporated in
2021
diclazuril/kg of
N.V.
Diclazuril: 0,50 g/100 g.
(Clinacox 0,5 %)
compound feed in
wet liver
Protein-poor soybean meal: 99,25 g/100 g
the form of a
1 000 μg
premixture.
Polyvidone K 30: 0,20 g/100 g
diclazuril/kg of
2. Diclazuril shall not
wet kidney
Sodium hydroxide: 0,05 g/100 g
icial
be mixed with
500 μg
other coccidiostats.
Jour
Characterisation of the active substance:
diclazuril/kg of
3. For safety:
wet muscle
nal
Diclazuril, C 17H 9Cl 3N 4O 2,
breathing
500 μg
of
(±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-
protection, glasses
diclazuril/kg of
the
tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]
and gloves shall be
wet skin/fat
acetonitrile,
used during
European
handling.
CAS number: 101831-37-2
4. A post-market
Related impurities:
monitoring
Union
Degradation compound (R064318): ≤ 0,1 %
program on the
resistance to
Other related impurities (T001434, R066891,
bacteria and
R068610, R070156, R070016):
Eimeria spp. shall
≤ 0,5 % individually
be planned and
Total impurities: ≤ 1,5 %
executed by the
holder of authori
Analytical method (1 ):
sation.
For determination of diclazuril in feed: reversed-
phase high performance liquid chromatography
(HPLC) using Ultraviolet detection at 280 nm
(Regulation (EC) No 152/2009)
For determination of diclazuril in poultry tissues:
HPLC coupled to triple quadrupole mass spec
trometer (MS/MS) using one precursor ion and
two product ions.
L
229/11
(1 ) Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

---